Medical Device Safety and Recalls: ICU Medical, Inc., ConMed Stat2 Flow Controller – Delivers Higher Flow Rate than Intended

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: ICU Medical, Inc., ConMed Stat2 Flow Controller – Delivers Higher Flow Rate than Intended

A recall has been issued for ICU Medical, Inc., ConMed Stat2 Flow Controller.  ICU Medical Inc., is recalling the Stat2 Flow Controller because it was assembled with the wrong internal component. As a result, the Flow Controller may deliver fluid at a much higher flow rate than what is set.  The use of the affected product may cause serious adverse health consequences, including death.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm418109.htm

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